Changes in Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious

Patent ductus arterious(PDA)is frequently seen and potentially pathologic in preterm infants. Near-infrared spectroscopy is a simple bedside tool to analyse the changes in the renal and splanchnic tissue oxygenation index and fractional tissue oxygen extraction and may be helpful to measure effects of ibuprofen treatment for PDA in preterm infants.

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Key information

Conditions

Ductus Arteriosus, Patent Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

2 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zekai Tahir Burak Maternity and Teaching Hospital

Ankara, Turkey (Türkiye)

About this study

Patent ductus arterious (PDA) is the most common cardiovascular abnormality in preterm infants.There are clear associations between a PDA and decreased renal and splanchnic blood flow. The aim is to monitor, using near-infrared spectroscopy, the effect of ibuprofen on the fractional tissue (renal and mesenteric) oxygen extraction (FTOE) in preterm newborns during ibuprofen of the treatment PDA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Gestational age <32 weeks and <1500 g
Echocardiographic evidence of hemodynamically significant patent ductus arterious

Exclusion criteria

Major congenital anomalies
Intraventricular hemorrhage of grade 3 within the previous 24 hours
Serum creatinine level 1.5 mg%,serum urea nitrogen concentration >50 mg%,
Platelet count 60 000/mL3, a tendency to bleed (defined by the presence of hematuria, blood in the endotracheal aspirate, gastric aspirate, or stools and/or oozing from puncture sites)
Hyperbilirubinemia necessitating exchange transfusion

Treatment and study plan

Near-infrared spectroscopy (NIRS)

Device

Non-invasive monitoring device measures the quantity of reflected light photons as a function of two wavelengths, and determines the spectral absorption of the underlying tissue.

Other names: INVOS 4100 oximeter, Somanetics,

Sponsors and collaborators

Lead sponsor

Zekai Tahir Burak Women's Health Research and Education Hospital

Other

Registry information

Official study title

Observational Study of Near Infrared Spectroscopy to Monitor Renal and Splanchnic Oxygenation During Ibuprofen Treatment for Patent Ductus Arterious in Preterm Infants

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Dec 2, 2010
Registry last updated: Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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